Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from
simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver
disease that can lead to cirrhosis and liver-related mortality in persons who drink little or
no alcohol. NAFLD is defined as the presence of hepatic steatosis with no evidence of
hepatocellular injury in the form of ballooning of the hepatocytes. NASH is defined as the
presence of hepatic steatosis and inflammation with hepatocyte injury (ballooning) with or
without fibrosis. NASH is benign in many affected individuals but can cause progressive liver
injury and, indeed, may be the major cause of cryptogenic cirrhosis1. Currently, there is no
FDA approved treatment for NAFLD. Weight loss and exercise are the recommended but often
difficult maintain these lifestyle changes in the long term and therefore therapeutic agents
have been investigated. In this study, we propose to treat 50 patients with NAFLD and
diabetes with either sitagliptin or placebo for 24 weeks. After an initial evaluation for
insulin sensitivity and MRI liver fat distribution, patients will receive either 100 mg/day
of sitagliptin or placebo. Patients will be monitored at regular intervals for symptoms of
liver disease, side effects of sitagliptin and serum biochemical and metabolic indices. At
the end of 24-weeks, patients will have a repeat medical evaluation, liver MRI and an
optional liver biopsy. Pre and post treatment MRI-derived liver fat content and insulin
sensitivity will be compared. The primary end point of successful therapy will be improvement
in hepatic steatosis measured by MRI. Secondary end points will be improvement in insulin
sensitivity and liver biochemistry.